Actively Recruiting

Phase 4
Age: 18Years +
MALE
Healthy Volunteers
ID04102566

Optimizing Pain Control After Transurethral Resection of the Prostate by Comparing Multi-Modal Pain Management to Standard Care

Led by Benaroya Research Institute · Updated on 2019-09-27

50

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

B

Benaroya Research Institute

Lead Sponsor

V

Virginia Mason Hospital/Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new approach to managing pain after transurethral resection of the prostate (TURP) that aims to reduce opioid use. The study compares a multi-modal pain control protocol, which combines two or more pain relief agents acting by different mechanisms, to the current standard care that primarily uses opioids. The goal is to provide similar pain relief while minimizing opioid use, addressing concerns related to the opioid epidemic in surgical patients. Participants are randomly assigned to one of two groups. The standard care group receives medications including topical lidocaine gel, acetaminophen, oxycodone, and other supportive drugs both during hospitalization and after discharge. The multi-modal group receives a regimen that adds ibuprofen and patient education about pain and opioid use, aiming to reduce opioid consumption. Both groups get similar supportive medications for urinary symptoms and constipation. The study period includes inpatient treatment and discharge medication prescriptions. During the study, participants' opioid use and pain levels are monitored from post-anesthesia care through 72 hours after surgery. Researchers also track the presence of urinary catheters at discharge, side effects from narcotics within 48 hours after discharge, and any post-operative complications. Participants are evaluated through medication usage records and pain scores to assess the effectiveness of the pain management protocols, ensuring careful monitoring of safety and outcomes throughout the study.

CONDITIONS

Brief Title

Optimizing Pain Control in Transurethral Resection of the Prostate

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Identified as candidates for TURP
  • 18 years of age or greater
  • Proficient in English
Not Eligible

You will not qualify if you...

  • Filled an opioid prescription in the last 2 months
  • Allergy to any medication included in the protocol
  • History of pelvic radiation
  • Renal failure with serum creatinine greater than 2.0 mg/dl
  • Peptic ulcer disease
  • History of gastric bypass
  • Cirrhosis or other contraindications to NSAIDs
  • Liver failure, hepatitis, or alcohol abuse preventing acetaminophen use

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Hospital stay (0 to 48 hours)

Participants undergo transurethral resection of the prostate (TURP) and receive assigned pain control management while hospitalized, either standard care or a multi-modal pain management protocol including medication and education.

1 hospital stay with medication administration

Post-operative Follow-up

Duration - Up to 72 hours after surgery

Participants are monitored for pain control, opioid consumption, presence of urinary catheter, narcotic side effects, and any post-operative complications after discharge.

Follow-up assessments within 72 hours post-surgery

Trial Site Locations

Total: 1 location

1

Virginia Mason Medical Center

Seattle, Washington, United States, 98101

Actively Recruiting

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Research Team

R

Ryan Donahue, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management.

American Society of Anesthesiologists Task Force on Acute Pain Management

https://pubmed.ncbi.nlm.nih.gov/22227789

Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial.

Brandon C Maughan, Elliot V Hersh, Frances S Shofer...

https://pubmed.ncbi.nlm.nih.gov/27663358